Lamotrigine Augmentation in Resistant Depression

Completed · Not applicable · Has a placebo group

Conditions studied: Unipolar Depression

In brief

This study is intended to evaluate the efficacy and safety of lamotrigine as an antidepressant augmentation agent in a sample of individuals with major depression and a history of both prior non-response and prospective failure to respond to at least one adequate trial of an antidepressant (for a total of two failed trials).

Key facts

Study ID

NCT00901407

Run by

Louisiana State University Health Sciences Center in New Orleans

People needed

138

Starts

2003-12-01

Expected to finish

2007-04-01

Last updated by the study team

2009-05-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, age 18-65
• A current primary diagnosis of unipolar major depression based on certain criteria
• Have a score of > 18 on the 17-item Hamilton Depression scale
• A history of prior failure of at least one adequate trial of an FDA-approved antidepressant. The antidepressant failure must have occurred within the current episode of major depression
• Females of childbearing potential will be allowed as long as they are taking adequate contraceptive precautions

You may not qualify if…

• A primary Axis I diagnosis other than primary unipolar major depression
• A history suggestive of hypomania or mania during the current episode or during the person's lifetime
• A history of psychosis, dementia, organic affective disorders or alcohol and/or substance abuse in the previous six months
• Individuals with a current or past diagnosis of schizoid, schizotypal, borderline or antisocial or any other current or past severe personality disorder
• Individuals with a current or past diagnosis of schizophrenia or schizoaffective disorder
• A history of failure to respond to electroconvulsive therapy during the current or any prior lifetime episode of major depression
• A history of failure of a prior adequate trial of paroxetine or paroxetine-CR for the treatment of Major Depression
• Significant, coexisting medical conditions that might make it unsafe to take either of the study medications, or in which any average reasonable clinician would assume that the medical condition may, in fact, be exacerbating the current episode of depression or impede the person's ability to recover fully from their depressive illness
• Presence of significant medical abnormalities on baseline laboratory values or physical examination, including vital signs
• Individuals with any significant abnormalities of thyroid function
• Subjects on thyroid supplementation must have been on a stable dose for six months prior to the screening visit
• Individuals who will require concomitant psychotropic medications, including benzodiazepines
• Subjects with severe insomnia will be allowed to take a maximum of 10 mg of zolpidem on two nights weekly at the investigator's discretion.
• Zolpidem may not be taken on the night before the study visit.
• Each dose of zolpidem should be listed on the concurrent medication case report form
• Medications likely to cause significant effects on mood and anxiety are also excluded
• Individuals with a positive urine drug screen for drugs of abuse at the screening visit
• Use during the time of the study of any medications known to affect the metabolism of lamotrigine
• Individuals on valproate and carbamazepine will be specifically excluded
• Investigators should be aware that oral contraceptives have been reported to lower the levels of lamotrigine, but any change in dosing is left to the judgment of the investigator
• Subjects who have taken other psychoactive drugs within certain time frames of the screening visit
• The presence of significant risk of suicide
• Pregnant females or those who are breastfeeding infants
• A history of hypersensitivity or intolerance to either of the study medications, lamotrigine or paroxetine or paroxetine-CR
• Subjects initiating or terminating psychotherapy within 12 weeks of the screening visit

Where it is running

• LSUHSC- New Orleans — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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